Device Dossier
Tube, tympanostomy
Device Dossier for Tube, tympanostomy (Tube, tympanostomy, Class IIb, sponsor Eon Meditech Au). ARTG record, intended purpose, GMDN category — compiled…
- GMDN category: Tube, tympanostomy
Intended purpose
Ear Ventilation Tubes are intended for ventilation or drainage of fluids from the middle ear. A tympanostomy tube is surgically inserted through an incision (myringotomy) which is made in the tympanic membrane. The primary purpose of the device is to ventilate the middle ear, allowing a free exchange of air between the outer ear and the middle ear space equalizing the pressure on both sides of the membrane and thus facilitate the drainage of fluids from the middle ear space through the Eustachian tube into the external auditory canal. Ventilation also prevents fluid accumulation within the middle ear. A secondary purpose is to provide an alternate route for the exit of middle ear fluid.